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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K051949
Device Name 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
Applicant
Triage Medical, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Applicant Contact GAYLE HIROTA
Correspondent
Triage Medical, Inc.
13700 Alton Pkwy.
Suite 160
Irvine,  CA  92618
Correspondent Contact GAYLE HIROTA
Classification Product Code
MRW  
Date Received07/15/2005
Decision Date 08/05/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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